RecruitingNot Applicable

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

United States20 participantsStarted 2019-12-04

Plain-language summary

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Who can participate

Age range

15 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5. * Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory . * No evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4. * Ages 15-35 * Non-smoker for past six months * Absence of suicidal ideation or behavior over the past month as assessed by the Columbia Suicide Severity Rating Scale * The American Association for Respiratory Care notes that "no absolute contraindications to oxygen therapy exist when indications \[for oxygen therapy\] are present."

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in cognitive functioning

Timeframe: 4 weeks

Change from baseline in quality of life

Timeframe: 4 weeks

Change from baseline in social functioning

Timeframe: 4 weeks

Change from baseline in role functioning

Timeframe: 4 weeks

Change from baseline in health-related quality of life

Timeframe: 4 weeks

Trial details

NCT IDNCT04368039

SponsorNicholas Breitborde

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-07

Contact for this trial

Nicholas Breitborde, PhD

(614) 685-6052 nicholas.breitborde@osumc.edu

View on ClinicalTrials.gov More Psychosis trials

Who can participate

Age range

15 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline in cognitive functioning

Timeframe: 4 weeks

Change from baseline in quality of life

Timeframe: 4 weeks

Change from baseline in social functioning

Timeframe: 4 weeks

Change from baseline in role functioning

Timeframe: 4 weeks

Change from baseline in health-related quality of life

Timeframe: 4 weeks